NCT03671018

A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma

An Open-Label, Randomized, Multicenter, Phase Ib/II Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 422 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of intravenous (IV) or subcutaneous (SC) mosunetuzumab in combination with polatuzumab vedotin in participants with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). It will consist of a dose finding portion followed by an expansion phase for second line or later (2L+) participants with relapsed or refractory (R/R) DLBCL and 2L+ R/R FL. In addition, subcutaneous mosunetuzumab in combination with polatuzumab vedotin will be evaluated in participants with at least 2 prior lines of systemic therapy (3L+) for the treatment of R/R mantle cell lymphoma (MCL) and in participants with 2L+ R/R DLBCL.

Conditions

• B-cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Mosunetuzumab (IV)	Participants will receive intravenous (IV) mosunetuzumab.
DRUG	Mosunetuzumab (SC)	Participants will receive subcutaneous (SC) mosunetuzumab.
DRUG	Polatuzumab vedotin	Participants will receive IV polatuzumab vedotin.
DRUG	Tocilizumab	Participants will receive IV tocilizumab as needed.
DRUG	Rituximab	Participants will receive IV rituximab.

Timeline

• Start date: 2018-09-25
• Primary completion: 2024-01-30
• Completion: 2025-07-20
• First posted: 2018-09-14
• Last updated: 2024-11-29

Locations

29 sites across 5 countries: United States, Belgium, Canada, Spain, United Kingdom

Regulatory

• FDA-regulated drug study